Events

Recall of Alegria Anti-Intrinsic Factor Assay

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Immuno Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2014-RN-00546-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00546-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Analysis in quality control has identified and confirmed that the lots listed above of our alegria test org 247, anti-intrinsic factor, exhibit an overall lower level of optical density values. this effect bears the risk that some positive sample-values will fall below the cut-off and will falsely be read as negative.
  • Action
    Immuno requested thier customers to destroy any remaining product from the affecetd lots. Due to the risk of false negative results Immuno recommended that negative samples where clinical symptoms of pernicious anaenia should be retested. This action has been closed-out on 18/02/2016.

Device

Alegria Anti-Intrinsic Factor Assay
  • Model / Serial
    Alegria Anti-Intrinsic Factor AssayProduct Code: ORG 247-24Lot Numbers: 24732425, 24732427 & 24733840
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA